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Table 2 Effect of treatment (modified intention-to-treat) on primary and secondary outcomes (n = 88)

From: Long-term efficacy and cost-effectiveness of blended cognitive behavior therapy for high fear of recurrence in breast, prostate and colorectal Cancer survivors: follow-up of the SWORD randomized controlled trial

  bCBT (n = 45) CAU (n = 43)  
Mean SE/SD* Mean SE/SD* Mean difference 95% CI p value
Primary outcome
 FCR (CWS)
  T0 19.622 3.737 19.558 3.744    
  T1 unadjusted 14.814 4.579 18.487 3.986    
  T1 adjusted 14.743 0.432 18.277 0.454 −3.534 −4.764 to −2.305 0.000
  T2 unadjusted 13.718 4.472 17.844 3.836    
  T2 adjusted 13.916 0.493 18.020 0.534 −4.104 −5.531 to − 2.677 0.000
  T3 unadjusted 14.684 4.539 16.516 4.081    
  T3 adjusted 14.783 0.504 16.570 0.549 −1.787 −3.251 to −0.323 0.017
Secondary outcomes
 Multidimensional aspects of FCR
  Severity (FCRI)
   T0 21.909 4.850 23.116 6.456    
   T1 unadjusted 16.605 7.251 22.282 5.991    
   T1 adjusted 16.989 0.756 21.330 0.788 −4.341 −6.497 to −2.185 0.000
   T2 unadjusted 15.025 6.897 21.313 5.171    
   T2 adjusted 15.957 0.688 20.462 0.742 −4.505 −6.513 to −2.497 0.000
   T3 unadjusted 15.842 7.343 19.733 5.539    
   T3 adjusted 16.599 0.805 19.023 0.879 −2.423 −4.785 to −0.062 0.044
Distress, depression, anxiety
 Distress (HADS)
  T0 14.089 7.836 15.209 8.911    
  T1 unadjusted 9.951 8.402 17.131 9.519    
  T1 adjusted 10.749 0.731 16.003 0.763 −5.254 −7.334 to −3.174 0.000
  T2 unadjusted 9.718 7.412 15.862 9.771    
  T2 adjusted 11.139 0.806 14.897 0.898 −3.759 −6.134 to −1.383 0.002
  T3 unadjusted 9.778 8.292 14.889 9.390    
  T3 adjusted 11.414 0.966 13.228 1.082 −1.813 −4.669 to 1.043 0.213
 Anxiety (HADS)
  T0 8.156 4.101 8.395 4.914    
  T1 unadjusted 5.317 4.239 9.447 5.012    
  T1 adjusted 5.639 0.437 8.951 0.456 −3.312 −4.555 to −2.068 0.000
  T2 unadjusted 5.333 4.132 8.862 5.585    
  T2 adjusted 6.030 0.528 8.549 0.588 −2.519 −4.074 to −0.964 0.002
  T3 unadjusted 4.944 4.056 8.333 4.844    
  T3 adjusted 5.751 0.570 7.734 0.638 −1.984 −3.667 to − 0.301 0.021
 Depression (HADS)
  T0 5.933 4.218 6.814 4.722    
  T1 unadjusted 4.634 4.598 7.684 5.152    
  T1 adjusted 5.050 0.424 7.131 0.442 −2.081 −3.286 to −0.876 0.001
  T2 unadjusted 4.385 4.017 7.000 4.751    
  T2 adjusted 5.042 0.418 6.406 0.467 −1.363 −2.597 to −0.130 0.030
  T3 unadjusted 4.833 4.675 6.556 4.956    
  T3 adjusted 5.582 0.504 5.611 0.565 −.029 −1.520 to 1.462 0.970
 Cancer-specific distress (IES)
  T0 23.044 14.555 24.902 15.604    
  T1 unadjusted 14.732 14.998 26.026 17.747    
  T1 adjusted 15.539 2.064 24.598 2.208 −9.059 −15.003 to −3.115 0.003
  T2 unadjusted 9.973 13.710 16.643 15.905    
  T2 adjusted 11.127 2.085 17.107 2.391 −5.979 −12.215 to 0.256 0.060
  T3 unadjusted 14.944 14.633 18.259 15.294    
  T3 adjusted 15.781 2.147 17.254 2.450 −1.473 −7.883 to 4.938 0.653
 Fatigue (CIS-8R)
  T0 30.222 12.951 36.116 12.585    
  T1 unadjusted 25.250 11.535 36.684 13.001    
  T1 adjusted 27.961 1.137 33.478 1.176 −5.516 −8.771 to −2.262 0.001
  T2 unadjusted 26.769 11.855 32.586 12.290    
  T2 adjusted 28.694 1.297 30.512 1.444 −1.818 −5.658 to 2.022 0.353
  T3 unadjusted 26.806 11.436 30.556 13.042    
  T3 adjusted 29.387 1.350 26.888 1.514 2.499 −1.522 to 6.521 0.223
Quality of life (EORTC QLQ-C30)
 Global quality of life
  T0 62.222 19.672 61.434 20.252    
  T1 unadjusted 73.062 19.402 57.479 20.483    
  T1 adjusted 72.504 2.556 58.075 2.682 14.429 7.153 to 21.705 0.000
  T2 unadjusted 72.083 21.229 62.500 21.792    
  T2 adjusted 71.918 3.004 62.632 3.264 9.286 0.576 to 17.997 0.037
  T3 unadjusted 73.026 19.609 65.278 19.948    
  T3 adjusted 72.672 2.823 67.742 3.108 4.930 −3.331 to 13.192 0.242
 Physical functioning
  T0 87.704 13.406 83.953 16.269    
  T1 unadjusted 89.380 11.735 80.855 20.010    
  T1 adjusted 87.552 1.527 82.886 1.606 4.666 .296 to 9.037 0.036
  T2 unadjusted 88.750 15.148 86.458 14.809    
  T2 adjusted 86.246 1.737 87.766 1.893 −1.519 −6.583 to 3.545 0.557
  T3 unadjusted 89.649 13.924 84.301 14.560    
  T3 adjusted 87.986 1.592 86.829 1.721 1.156 −3.479 to 5.792 0.625
 Role functioning
  T0 77.037 26.181 74.806 25.295    
  T1 unadjusted 85.659 21.076 74.123 23.474    
  T1 adjusted 84.543 2.963 75.547 3.142 8.996 0.503 to 17.489 0.038
  T2 unadjusted 83.750 23.415 82.292 21.972    
  T2 adjusted 82.766 3.407 82.705 3.742 0.061 −9.887 to 10.008 0.991
  T3 unadjusted 89.035 17.013 84.409 23.148    
  T3 adjusted 87.388 2.777 85.357 3.043 2.031 −6.095 to 10.157 0.624
 Emotional functioning
  T0 64.815 22.883 66.860 22.456    
  T1 unadjusted 81.589 23.185 60.256 29.830    
  T1 adjusted 81.647 2.934 59.978 3.078 21.669 13.326 to 30.011 0.000
  T2 unadjusted 80.208 22.463 61.719 28.544    
  T2 adjusted 78.959 3.259 60.785 3.540 18.174 8.731 to 27.617 0.000
  T3 unadjusted 77.851 23.592 68.548 25.973    
  T3 adjusted 77.507 2.987 68.668 3.242 8.839 0.179 to 17.499 0.046
 Cognitive functioning
  T0 72.963 24.692 68.992 25.350    
  T1 unadjusted 80.620 19.897 62.393 28.541    
  T1 adjusted 79.977 2.920 64.662 3.071 15.315 6.989 to 23.641 0.000
  T2 unadjusted 82.500 19.954 72.917 28.945    
  T2 adjusted 80.130 3.276 74.990 3.593 5.140 −4.421 to 14.701 0.292
  T3 unadjusted 79.386 22.738 68.280 25.587    
  T3 adjusted 76.994 3.171 71.780 3.442 5.214 −4.013 to 14.441 0.268
 Social functioning
  T0 80.000 23.192 71.318 24.754    
  T1 unadjusted 89.922 17.495 76.923 26.384    
  T1 adjusted 87.868 2.907 79.225 3.055 8.643 0.306 to 16.979 0.042
  T2 unadjusted 85.833 22.504 80.208 22.175    
  T2 adjusted 83.302 3.052 81.127 3.310 2.176 −6.727 to 11.078 0.632
  T3 unadjusted 88.158 19.723 86.022 19.292    
  T3 adjusted 85.924 2.556 89.059 2.759 3.135 −10.641 to 4.370 0.413
  1. NOTE. Linear mixed-effects models were used to calculate all p-values. Adjusted means were adjusted for the baseline covariates primary cancer site and baseline value of the corresponding outcome; unadjusted means were unadjusted for covariates. Boldface type indicates a statistically significant effect for adjusted means (p < 0.05)
  2. *SEs are reported for adjusted means, SDs for unadjusted means
  3. Abbreviations: bCBT blended cognitive behaviour therapy, CAU care as usual; FCR fear of cancer recurrence, CWS Cancer Worry Scale, FCRI Fear of Cancer Recurrence Inventory, HADS Hospital Anxiety and Depression Scale, IES Impact of Events Scale, CIS-8R Checklist Individual Strength 8R, EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, SD standard deviation, SE standard error